Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome

Plain-language guide to NCT01444898: not phased interventional trial of Exenatide, 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01444898
Phase: not phased
Status: completed
Start: 2012-03
Completion (planned or actual): 2013-05
Participants: 10 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Prader-Willi Syndrome
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Exenatide.

Prader-Willi Syndrome (PWS) is one of the most common genetic causes of obesity.

Obesity is a major source of morbidity and mortality in this population.

It can lead to sleep apnea, cor pulmonale, diabetes mellitus, and atherosclerosis.

It had 1 arm (groups): Exenatide (experimental).

The registry classes the interventions as drug.

More on the Plan

OBJECTIVE: The objective of this study is to determine the effect of a 6-month trial of exenatide on appetite, weight and gut hormones in youth with PWS.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 13 years up to 20 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of Prader Willi Syndrome confirmed by genetic testing (DNA methylation or FISH). Ages 13-20 years. Body mass index (BMI) \> 85th percentile for age and gender.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: is currently using or has previously used a glucagon-like peptide-1 (glp-1) agonist; history of pancreatitis, or renal failure; history of familial pancreatitis.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Exenatide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-03 with completion listed for 2013-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Weight (time frame: 6 months). % Change in Body Mass Index (BMI) (time frame: 6 months). Change in BMI Z-Score (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a not phased trial of Exenatide in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.

Our Notes on the Compound

Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.

Exenatide in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.